Guide wire for use in re-canalising a vascular occlusion in a human or animal subject

ABSTRACT

A guidewire ( 1 ) for re-canalizing a vascular occlusion comprises a core wire ( 5 ) which terminates at its distal end ( 4 ) in a terminal member ( 7 ) for opening the occlusion. A helical coil sleeve ( 10 ) extends around the core wire ( 5 ) from the terminal member ( 7 ) to a location ( 11 ) along the core wire ( 5 ). The terminal member ( 7 ) defines first and second planar surface portions ( 13, 14 ), which converge towards a distal transversely extending leading edge portion ( 8 ). In use, as the terminal member ( 7 ) is urged through the vascular occlusion, the first and second surface portions ( 13, 14 ) act on the occlusion to form an opening therethrough. A distal portion ( 28 ) of the core wire ( 5 ) is of spade-like configuration for facilitating bending thereof for directing the terminal member ( 7 ) out of a central major plane ( 35 ) defined by the distal portion ( 28 ) for facilitating aligning of the terminal member ( 7 ) with a branched vessel of the vascular system.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 13/337,490, filed on Dec. 27, 2011, which is a continuation ofU.S. patent application Ser. No. 10/590,866, filed on Sep. 19, 2006, nowU.S. Pat. No. 8,092,395, which is a National Stage Entry ofInternational application No. PCT/IE05/00031, filed on Mar. 25, 2005.

BACKGROUND OF THE INVENTION

The present invention relates to a guide wire for use in a re-canalisingprocess of a vascular occlusion in a human or animal subject, and inparticular, for re-canalising a blocked or partially blocked artery, forexample, in the cardiovascular system, although the invention is notlimited to a guide wire for such use. The invention also relates to amethod for re-canalising a vascular occlusion in a human or animalsubject.

Guide wires are commonly used for guiding a catheter carrying atherapeutic or other device to a remote location in the vascular systemof a subject. For example, where a vessel is occluded or partiallyoccluded, a guide wire is used for guiding a catheter which may carry aballoon or a stent at its distal tip for locating in the artery in theoccluded part thereof for maintaining a passage through the occlusion.However, prior to the insertion of the stent or other such device, theocclusion must be penetrated in order to open a passage therethrough foraccommodating the stent.

Guide wires are provided for penetrating such occlusions or partialocclusions prior to the insertion of the catheter over the guide wire.U.S. Pat. No. 6,348,040 of Stalker, et al discloses such a catheterwhich is provided with a vibrating tip. However, a disadvantage of theguide wire disclosed in this U.S. patent specification is that in orderto provide the vibrating tip, relatively expensive and, moreimportantly, cumbersome equipment is required, which must be attached tothe guide wire

U.S. Pat. No. 6,669,652 of Anderson, et al discloses a guide wire, whichcomprises a core wire and a helical coil extending around a distalportion of the core wire. The helical coil extends beyond the distal endof the core wire, and tapers to a distal point for penetrating theocclusion as the guide wire is urged forwardly. One disadvantage of theguide wire disclosed in this U.S. specification is that due to the factthat the tip is pointed, there is a danger of the tip penetrating thewall of a vessel of the vascular system as the guide wire is being urgedto the occlusion. Another disadvantage of this guide wire is that theportion of the helical coil which extends beyond the distal end of thecore wire is relatively flaccid, and thus renders the guide wiredifficult to guide through the vascular system, and in particular avascular system with branched vessels.

U.S. Pat. Nos. 5,527,298 and 5,127,917 disclose guide wires in which thedistal end of the guide wires terminate in bulbous distal tip portions.The distal tip portions are of transverse cross-sectional areasignificantly greater than the transverse cross-sectional area of theguide wire, and taper to a distal point. The distal point facilitatespenetration of the occlusion, and the tapering portion facilitates ineasing the guide wire through the occlusion. However, a disadvantage ofthe guide wires disclosed in these two U.S. patent specifications isthat due to the fact that the transverse cross-sectional area of thebulbous distal tip portions are significantly greater than thetransverse cross-sectional area of the guide wire, difficulty isexperienced in subsequently urging a catheter over the bulbous tipportions.

There is therefore a need for a guide wire which is suitable for use ina re-canalising process of a vascular occlusion in a human or animalsubject.

SUMMARY OF THE INVENTION

The present invention is directed towards providing such a guide wire,and the invention is also directed towards providing a method forre-canalising a vascular occlusion in a human or animal subject.

According to the invention there is provided a guide wire for use in are-canalising process for re-canalising a vascular occlusion in a humanor animal subject, the guide wire extending between a proximal end and adistal end, and defining a longitudinally extending main central axis,wherein the guide wire terminates at its distal end in a terminal memberextending axially from the guide wire, the terminal member tapering to adistal leading tip portion for engaging and gradually opening theocclusion as the terminal member is urged therethrough.

Preferably, the leading edge portion is an elongated leading edgeportion. Advantageously, the leading edge portion extends in a directionat an angle relative to an axial direction defined by the main centralaxis.

In one embodiment of the invention the leading edge portion extends in adirection at an angle in the range of 1° to 90°. relative to an axialdirection defined by the main central axis. Preferably, the leading edgeportion extends in a direction at an angle in the range of 45° to 90°relative to an axial direction defined by the main central axis.Advantageously, the leading edge portion extends in a direction at anangle of approximately 60° relative to an axial direction defined by themain central axis.

In one embodiment of the invention the leading edge portion extends in adirection substantially transversely of the main central axis.

In one embodiment of the invention a first surface portion of theterminal member converges towards an opposite second surface portionthereof towards the leading edge portion.

In another embodiment of the invention the first surface portion of theterminal member is planar.

In a further embodiment of the invention the first surface portion ofthe terminal member is convex in a longitudinal direction relative tothe main central axis.

In a still further embodiment of the invention the first surface portionof the terminal member is concave in a longitudinal direction relativeto the main central axis.

In a still further embodiment of the invention the first surface portionof the terminal member is sequentially convex and concave in alongitudinal direction relative to the main central axis.

In one embodiment of the invention a distal portion of the first surfaceportion of the terminal member is concave in a longitudinal directionrelative to the main central axis.

In another embodiment of the invention a proximal portion of the firstsurface portion of the terminal member is convex in a longitudinaldirection relative to the main central axis.

In another embodiment of the invention the first surface portion of theterminal member is convex in a transverse direction relative to the maincentral axis.

In a further embodiment of the invention the second surface portion ofthe terminal member converges towards the first surface portion towardsthe leading edge portion.

In one embodiment of the invention the second surface portion of theterminal member is planar.

In another embodiment of the invention the second surface portion of theterminal member is convex in a longitudinal direction relative to themain central axis.

In a further embodiment of the invention the second surface portion ofthe terminal member is concave in a longitudinal direction relative tothe main central axis.

In a still further embodiment of the invention the second surfaceportion of the terminal member is sequentially convex and concave in alongitudinal direction relative to the main central axis.

In a still further embodiment of the invention a distal portion of thesecond surface portion of the terminal member is concave.

In a further embodiment of the invention a proximal portion of thesecond surface portion of the terminal member is convex.

In one embodiment of the invention the second surface portion of theterminal member is convex in a transverse direction relative to the maincentral axis.

Preferably, the first and second surface portions terminate in theleading edge portion to define the leading edge portion as a chiseledge.

In one embodiment of the invention the first and second surface portionsof the terminal member define an included angle in the range of 1° to179°. Preferably, the first and second surface portions of the terminalmember define an included angle in the range of 5° to 90°.Advantageously, the first and second surface portions of the terminalmember define an included angle of approximately 15°.

In one embodiment of the invention the first and second surface portionsof the terminal member are joined by spaced apart opposite third andfourth surface portions. Preferably, the leading edge portion of theterminal member extends between the third and fourth surface portions.

In one embodiment of the invention the third and fourth surface portionsof the terminal member are planar surfaces. In an alternative embodimentof the invention the third and fourth surface portions of the terminalmember are convex in a transverse direction relative to the main centralaxis.

In another embodiment of the invention the third and fourth surfaceportions of the terminal member are parallel to each other in an axialdirection defined by the main central axis.

Alternatively, the third and fourth surface portions of the terminalmember taper towards the leading edge portion.

In one embodiment of the invention the third and fourth surface portionsof the terminal member define an included angle in the range of 1° to179°. Preferably, the third and fourth surface portions of the terminalmember define an included angle in the range of 5° to 90°.Advantageously, the third and fourth surface portions of the terminalmember define an included angle of approximately 15°.

In one embodiment of the invention the third surface portion of theterminal member is convex in a longitudinal direction relative to themain central axis. Alternatively, the third surface portion of theterminal member is concave in a longitudinal direction relative to themain central axis.

In another embodiment of the invention the third surface portion of theterminal member is sequentially convex and concave in a longitudinaldirection relative to the main central axis.

In a still further embodiment of the invention a distal portion of thethird surface portion of the terminal member is concave in alongitudinal direction relative to the main central axis, and in afurther embodiment of the invention a proximal portion of the thirdsurface portion of the terminal member is convex in a longitudinaldirection relative to the main central axis.

In one embodiment of the invention the fourth surface portion of theterminal member is convex in a longitudinal direction relative to themain central axis. Alternatively, the fourth surface portion of theterminal member is concave in a longitudinal direction relative to themain central axis.

In one embodiment of the invention the fourth surface portion of theterminal member is sequentially convex and concave in a longitudinaldirection relative to the main central axis. In a further embodiment ofthe invention a distal portion of the fourth surface portion of theterminal member is concave in a longitudinal direction relative to themain central axis, and in a still further embodiment of the invention aproximal portion of the fourth surface portion of the terminal member isconvex in a longitudinal direction relative to the main central axis.

Preferably, the leading edge portion is radiused from the first surfaceportion of the terminal member to the second surface portion thereof.Advantageously, the leading edge portion is radiused in plan view.

In another embodiment of the invention the leading edge portion isconvex in plan view. Alternatively, the leading edge portion is concavein plan view.

In one embodiment of the invention the maximum outer transversecross-sectional area of the terminal member is substantially similar tothe outer transverse cross-sectional area of the guide wire adjacent theterminal member. Preferably, the outer transverse cross-sectional areaof the terminal member adjacent the guide wire is similar to the outertransverse cross-sectional area of the guide wire adjacent the terminalmember so that the outer surface of the terminal member is in axialalignment with the outer surface of the guide wire adjacent the terminalmember. Advantageously, the guide wire adjacent the terminal member andthe terminal member adjacent the guide wire are of circular transversecross-section, and are of substantially similar outer diameters.

Advantageously, the transverse width of the leading edge portion issubstantially similar to the transverse width of the guide wire adjacentthe terminal member in a plane containing the leading edge portion andextending parallel to the main central axis.

In one embodiment of the invention the guide wire comprises an elongatedcore wire extending from the proximal end to the distal end. Preferably,the terminal member is secured to the distal end of the core wire.

Advantageously, the core wire terminates in a distal portion ofrectangular transverse cross-section defining first and second oppositemajor surfaces joined by first and second opposite minor surfaces forfacilitating bending thereof for offsetting the terminal member relativeto the main central axis for facilitating guiding of the terminal memberinto a branched vessel of a vascular system.

In one embodiment of the invention the first and second major surfacesof the distal portion of the core wire converge towards each othertowards the distal end thereof. Alternatively, the first and, secondmajor surfaces of the distal portion of the core wire extendsubstantially parallel to each other.

In another embodiment of the invention the first and second minorsurfaces of the distal portion of the core wire diverge from each othertowards the distal end thereof. Alternatively, the first and secondminor surfaces of the distal portion of the core wire extendsubstantially parallel to each other.

In one embodiment of the invention a reinforcing means is provided onthe distal portion of the core wire for minimising axial twistingthereof.

In another embodiment of the invention the first and second majorsurfaces of the distal portion of the core wire define therebetween acentral major plane extending parallel to the main central axis andcutting the first and second minor surfaces, and the distal portion iscurved in the central major plane for offsetting the terminal memberrelative to the main central axis for in turn facilitating guiding ofthe terminal member into a branched vessel of a vascular system.

Preferably, the central major plane defined by the first and secondmajor surfaces of the distal portion of the core wire extendstransversely of a plane containing the leading edge portion of theterminal member and extending parallel to the main central axis.

Advantageously; the central major plane defined by the first and secondmajor surfaces of the distal portion of the core wire extendssubstantially parallel to a plane containing the leading edge portion ofthe terminal member and extending parallel to the main central axis.

In one embodiment of the invention the core wire extending from thedistal portion thereof to the proximal end is of circular transversecross-section.

In another embodiment of the invention a sleeve extends along the corewire from the terminal member and terminates at a location intermediatethe distal end and the proximal end of the core wire. Preferably, thesleeve is of external circular transverse cross-section. Advantageously,the external diameter of the sleeve is substantially similar to thediameter of the terminal member adjacent the guide wire. Ideally, thesleeve comprises a helical coil located around the core wire adjacentthe distal end thereof.

In one embodiment of the invention a plug extends from the terminalmember adjacent a proximal end thereof for engaging an internal boredefined by the sleeve for securing the sleeve to the terminal member.

Preferably, the terminal member is secured to the sleeve by brazing orsoldering.

Advantageously, a core wire engaging bore extends into the terminalmember for engaging the distal end of the core wire.

Preferably, the core wire engaging bore extends axially into theterminal member.

Advantageously, the terminal member is secured to the core wire bybrazing, soldering, welding or adhesive. Ideally, the soldering orbrazing, soldering, welding or adhesive material is a radiopaquematerial.

In one embodiment of the invention the terminal member is of radiopaquematerial.

In another embodiment of the invention at least a portion of theterminal member is of a magnetic material for facilitating urging of theterminal member through a vascular system by a magnetic urging meanslocated externally of the subject.

In a further embodiment of the invention the terminal member is of amagnetic material.

In one embodiment of the invention a distal portion of the guide wire isof a magnetic material for facilitating urging of the terminal memberthrough a vascular system by a magnetic urging means located externallyof the subject.

The invention also provides in combination the guide wire according tothe invention and a magnetic urging means for urging the terminal memberthrough a vascular occlusion.

Preferably, the magnetic urging means for urging the terminal memberthrough a vascular system to a vascular occlusion.

The invention also provides a method for re-canalising a vascularocclusion in a human or animal subject, the method comprising urging theterminal member of the guide wire according to the invention through theocclusion for gradually opening thereof.

Preferably, the terminal member is urged by the guide wire through avascular system to the occlusion prior to being urged through theocclusion.

Advantageously, the terminal member is urged through the occlusion by amagnetic urging means located externally of the subject.

Ideally, the terminal member is urged through a vascular system by amagnetic urging means located externally of the subject.

The advantages of the invention are many. The guide wire according tothe invention is particularly suitable for use in re-canalising avascular occlusion in a vascular system in a human or animal body, andin particular, for use re-canalising an occluded or partially occludedvessel in the cardiovascular system of the human or animal body. Byvirtue of the fact that the terminal member tapers to a distal leadingedge portion, the distal leading edge portion initially engages thevascular occlusion, and as the terminal member is urged through thevascular occlusion, the tapering portion of the terminal membergradually opens the occlusion, until the terminal member opens theocclusion to define a bore of transverse cross-section corresponding tothe maximum external transverse cross-sectional area of the terminalmember.

By providing the terminal member to be of transverse cross-sectionalarea substantially similar to that of the guide wire, so that the outersurface of the terminal member is aligned with and substantiallycoincides with the outer surface of the guide wire, a catheter can bereadily easily passed over the guide wire and over the terminal member,without snagging on the terminal member.

A particular advantage is achieved when the terminal member terminatesin a transversely extending distal leading edge portion. Thetransversely extending leading edge portion facilitates ease ofpenetration of the vascular occlusion, and subsequent gradual opening ofthe vascular occlusion as the transversely extending leading edgeportion is urged through the occlusion. By providing the terminal memberwith respective opposite first and second surface portions whichconverge towards each other towards the distal leading tip portion, aparticularly advantageous form of the terminal member is obtained, andthe terminal member is particularly suitable for gradually opening thevascular occlusion as the terminal member is urged therethrough. Byproviding the first and second converging surface portions as planarsurface portions, a further advantage is achieved in that the rate ofpenetration of the occlusion can be maintained relatively constantthrough the constant increase in surface contact. Tapering the third andfourth surface portions of the terminal member further enhances thisadvantage.

The provision of the terminal member with a first surface portion whichis either convex or concave, or is sequentially convex and concave fromthe proximal to the distal end thereof, provides a gradual transitionfrom the tapering portion of the terminal member to the guide wire.

By providing the terminal member of a magnetic material, the terminalmember can be urged through the vascular system by a magnetic fieldgenerated by a suitable magnetic urging device located externally of thesubject. This has the added advantage that the terminal member can beurged through the vascular system by the magnetic field, rather than bypushing the guide wire into the subject. By being able to urge theterminal member through the vascular system by an externally generatedmagnetic field in particular facilitates in directing the terminalmember into a branched vessel of a vascular system, without the need topre-bend the guide wire. Additionally, by urging the terminal member byan externally generated magnetic field, the risk of puncturing a vesselof the vascular system as the terminal member is being urgedtherethrough is minimized.

Additionally, since it is important that the guide wire remain flexiblein order to negotiate the tortuous vascular systems of the anatomy, bymagnetically pulling the guide wire through the vascular system, theguide wire can be provided to be considerably more flexible than wouldbe the case where the guide wire is being provided to be pushed throughthe vascular system. The more flexible a guide wire is, the less easy itis to guide it through the vascular system by pushing. Thus, in order tofacilitate relatively accurate guiding of a guide wire through thevascular system which is to be pushed through the vascular system, theguide wire must be of lesser flexibility than where the guide wire isbeing pulled through the vascular system. Additionally, by providing theguide wire to be magnetically pulled through the vascular system, thereis a lesser risk of the terminal member entering a false lumen betweenthe laminae of a vessel.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more clearly understood from the followingdescription of some preferred embodiments thereof, which are given byway of example only, with reference to the accompanying drawings, inwhich:

FIG. 1 is a side elevational view of a guide wire according to theinvention,

FIG. 2 is a perspective view of a portion of the guide wire of FIG. 1,

FIG. 3 is another perspective view of the portion of FIG. 2 of the guidewire of FIG. 1,

FIG. 4 is a transverse cross-sectional side elevational view of theguide wire of FIG. 1,

FIG. 5 is a partly transverse cross-sectional side elevational view of aportion of the guide wire of FIG. 1,

FIG. 6 is a partly transverse cross-sectional plan view of the portionof FIG. 5, on the line VI-VI of FIG. 5 of the guide wire of FIG. 1,

FIG. 7 is a transverse cross-sectional side elevational view of aportion of the guide wire of FIG. 1,

FIG. 8 is an end elevational view of the portion of FIG. 7 of the guidewire of FIG. 1,

FIG. 9 is a side elevational view of another portion of the guide wireof FIG. 1,

FIG. 10 is a transverse cross-sectional side elevational view of aportion of the guide wire of FIG. 1 with a portion of the guide wirecurved,

FIG. 11 is a transverse cross-sectional side elevational view similar toFIG. 7 of a detail similar to that of FIG. 7 of a guide wire accordingto another embodiment of the invention,

FIG. 12 is a transverse cross-sectional side elevational view similar toFIG. 7 of a detail similar to that of FIG. 7 of a guide wire accordingto another embodiment of the invention,

FIG. 13 is a perspective view of a portion of a guide wire according toanother embodiment of the invention,

FIG. 14 is a perspective view of a portion of a guide wire according toa further embodiment of the invention,

FIG. 15 is a perspective view of a portion of a guide wire according toa still further embodiment of the invention,

FIG. 16 is a perspective view of a portion of a guide wire according toa further embodiment of the invention,

FIG. 17 is an end elevational view of the portion of the guide wire ofFIG. 16,

FIG. 18 is a perspective view of a part of the portion of the guide wireof FIG. 16,

FIG. 19 is a side elevational view of a portion of a guide wireaccording to a still further embodiment of the invention,

FIG. 20 is a top plan view of the portion of the guide wire of FIG. 19,

FIG. 21 is an end view of the portion of the guide wire of FIG. 19,

FIG. 22 is a top plan view of a portion of a guide wire according toanother embodiment of the invention,

FIG. 23 is an end elevational view of the portion of the guide wire ofFIG. 22,

FIG. 24 is a top plan view of a portion of a guide wire according to afurther embodiment of the invention,

FIG. 25 is an end elevational view of the portion of the guide wire ofFIG. 24,

FIG. 26 a top plan view of a portion of a guide wire according toanother embodiment of the invention,

FIG. 27 is an end elevational view of the portion of the guide wire ofFIG. 26,

FIG. 28 is a top plan view of a portion of a guide wire according toanother embodiment of the invention,

FIG. 29 is an end elevational view of the portion of the guide wire ofFIG. 28,

FIG. 30 is a perspective view of the portion of the guide wire of FIG.28,

FIG. 31 is a perspective view of a portion of a guide wire according toanother embodiment of the invention,

FIG. 32 is a perspective view of a part of the portion of the guide wireof FIG. 31,

FIG. 33 is a perspective view of a portion of a guide wire according toanother embodiment of the invention,

FIG. 34 is a perspective view of a part of the portion of the guide wireof FIG. 33,

FIG. 35 is a perspective view of a portion of a guide wire according toa further embodiment of the invention,

FIG. 36 is a perspective view of a portion of a guide wire according toa still further embodiment of the invention,

FIG. 37 is an end elevational view of the portion of the guide wire ofFIG. 36,

FIG. 38 is a side elevational view of a portion of a guide wireaccording to a still further embodiment of the invention, and

FIG. 39 is a top plan view of the portion of the guide wire of FIG. 38.

DETAILED DESCRIPTION OF THE INVENTION

Referring to the drawings and initially to FIGS. 1 to 10, there isillustrated a guide wire according to the invention, indicated generallyby the reference numeral 1, for use in a re-canalising process forre-canalising a vascular occlusion in a vascular system of a human oranimal subject. The guide wire 1 extends between a proximal end 3 and adistal end 4 and comprises a core wire 5 of circular transversecross-section and of stainless steel material which extends from theproximal end 3 to the distal end 4, and defines a longitudinallyextending main central axis 6. A terminal member 7 of circulartransverse cross-section adjacent its proximal end portion 16 defines acentral axis 9, and is secured to the core wire 5 at its distal end 4,and extends axially therefrom with the central axis 9 of the terminalmember 7 coinciding with the main central axis 6 of the core wire 5. Theterminal member 7 tapers to a distal leading edge portion, which in thisembodiment of the invention is a transversely extending elongatedleading edge portion 8 in the form of a chisel edge for engaging andpenetrating the occlusion or partial occlusion in a vessel of thevascular system as the guide wire 1 is urged through the vascularsystem. The leading edge portion 8 extends at 90.degree. to the maincentral axis 6. A sleeve, in this embodiment of the invention providedby a tightly wound helical coil 10 of stainless steel material issecured to the terminal member 7 at the proximal end portion 16 thereof,and extends therefrom over the core wire 5, and terminates at a location11 intermediate the proximal end 3 and the distal end 4 of the guidewire 1, but towards the distal end 4. The helical coil 10 is of circulartransverse cross-section, and defines a bore 12 of circular transversecross-section.

The terminal member 7 is of radiopaque material, in this embodiment ofthe invention platinum alloy, so that it is visible under X-rays as theguide wire 1 is being urged through the vascular system. The outerdiameter of the terminal member 7 at its proximal end portion 16 isconstant and is substantially similar to the outer diameter of thehelical coil 10 adjacent the terminal member 7 so that as a catheter isbeing urged along the guide wire 1, the catheter can readily easily beurged over the terminal member 7. The terminal member 7 defines a firstsurface portion 13 and a second surface portion 14 which convergetowards each other and terminate in the leading edge portion 8. In thisembodiment of the invention the first and second surface portions 13 and14 are planar, and the leading edge portion 8 is radiused, with a radiusr, between the first and second surface portions 13 and 14 to form theleading edge portion 8 to be convex in a plane perpendicular to a planecontaining the leading edge portion 8. The radius r of the convexsurface 15 of the leading edge portion 8 is sufficiently large toprovide the leading edge portion 8 to be sufficiently blunt to preventthe leading edge portion 8 penetrating a wall of a vessel of thevascular system, but not so blunt as would prevent the leading edgeportion 8 penetrating an occlusion or a partial occlusion in a vessel ofthe vascular system. The first and second surface portions 13 and 14define an included angle α, see FIG. 7, which is sufficiently acute forgradually opening the occlusion as the terminal member 7 is urgedtherethrough, while at the same time avoiding detaching any of theoccluding material from the vessel, in order to avoid urging theoccluding material forwardly with the guide wire 1. The first and secondsurface portions 13 and 14 are joined by third and fourth surfaceportions 18 and 21, respectively, which extend from the proximal endportion 16 of the terminal member 7 to the leading edge portion 8. Thethird and fourth surface portions 18 and 21 are radiused, and are of thesame radius as the outer surface of the proximal end portion 16, andthus, coincide with the outer surface of the proximal end portion 16,and are convex in a transverse direction relative to the main centralaxis 6.

The first and second surface portions 13 and 14 define a central majorplane 26 which bisects the included angle α defined by the first andsecond surface portions 13 and 14. In this embodiment of the inventionthe central major plane 26 defined by the first and second surfaceportions 13 and 14 contains the main central axis 6 and they leadingedge portion 8. The transverse width of the leading edge portion 8 isthus similar to the diameter of the proximal end portion 16 of theterminal member 7, and furthermore, the transverse cross-section of theportion of the terminal member formed by the first and second surfaceportions 13 and 14 is such as not to extend beyond the outer transversecross-sectional profile of the circular proximal end portion 16 of theterminal member 7.

In this embodiment of the invention the included angle α defined by thefirst and second surface portions 13 and 14 of the terminal member 7 isapproximately 15.degree., however, it is envisaged that the includedangle α defined by the first and second surface portions 13 and 14 maybe any acute angle in the range 5° to 60°, although it is believed thatit is preferable that the acute angle α defined by the first and secondsurface portions 13 and 14 should lie in the range 12° to 30°. In thisembodiment of the invention the radius r of the radiused convex surface15 of the leading edge portion of the terminal member 7 is approximately0.075 mm, although it is envisaged that the radius of the radiusedconvex surface 15 may lie in the range 0.02 mm, to 0.14 mm, although itis believed that it is preferable that the radius r should lie withinthe range 0.05 mm to 0.10 mm.

A plug 17 extends axially from the terminal member 7 for engaging thebore 12 in the helical coil 10 at the distal end thereof. The diameterof the plug 17 is such that the difference between the diameter of theplug 17 and the diameter at the proximal end portion 16 of the terminalmember 7 is equal to twice the diameter of the wire forming the helicalcoil 10, so that when the plug member 17 is engaged in the bore 12 ofthe helical coil 10, the outer surface defined by the helical coil 10substantially coincides with the outer surface of the proximal endportion 16 of the terminal member 7. A bore 19 extends axially into theplug 17 and into the terminal member 7 for accommodating the distal end4 of the core wire 5 for securing the terminal member 7 to the core wire5. In this embodiment of the invention the core wire 5 and the helicalcoil 10 are soldered to the terminal member 7 by solder 20 which fillsthe bore 19 as well as a distal portion of the bore 12 of the helicalcoil 10 for securing the terminal member 7 to the core wire 5 and thehelical coil 10.

The core wire 5 commences to taper at a location 22 at the proximal sideof the location 11 at which the helical coil 10 terminates, and tapersto its distal end 4. In this embodiment of the invention the core wire 5tapers in steps as is illustrated in FIG. 4. The core wire 5 tapers fromthe location 22 to a first portion 23 of constant diameter, and tapersfrom the first portion 23 to a second portion 24 of constant diameter,and in turn tapers from the second portion 24 to a third portion 25 ofconstant diameter. A distal portion 28 extends from the third portion 25at 29 to a transversely extending distal tip 30, and is of spade-likeconfiguration having a rectangular transverse cross-section. The distalportion 28 defines a first major surface 32 and a second major surface33, which are joined by opposite minor surfaces 34. The first and secondmajor surfaces 32 and 33 converge towards each other towards the distaltip 30, while the minor surfaces 34 diverge away from each other towardsthe distal tip 30. The first and second major surfaces 32 and 33 definetherebetween a central major plane 35 which contains the transverselyextending distal tip 30 and the main central axis 6, and extendsperpendicular to the minor surfaces 34. The spade-like configuration ofthe distal portion 28 facilitates bending of the guide wire at thedistal portion 28 for urging the terminal member 7 out of the centralmajor plane 35 for facilitating aligning the guide wire 1 with abranching vessel of the vascular system and directing the terminalmember 7, and in turn the guide wire 1 into the branching vessel.

A reinforcing means, in this embodiment of the invention provided by areinforcing rib 36 extends longitudinally along the first major surface32 of the distal portion 28 from the location 29, and terminates at alocation 37 intermediate the location 29 and the distal tip 30 forminimizing torsional twisting of the core wire along the distal portion28. Where the distal portion 28 is to be bent for bending the terminalmember 7 out of the central major plane 35, the distal portion 28 isbent between the location 37 and the terminal member 7.

A portion 38 of the distal portion 28 of the core wire 5 may be curvedin the central major plane 35 as illustrated in FIG. 10 for directingthe terminal member 7 out of a central minor plane 39 defined betweenthe minor surfaces 34 and containing the main central axis 6 andextending perpendicularly of the first and second major surfaces 32 and33. Forming the curved portion 38 in the distal portion 28 alsofacilitates aligning of the terminal member 7 with a branched vessel ofthe vascular system, and directing the terminal member 7; and in turn,the guide wire 1 into the branched vessel. When the guide wire 1 isprovided with the distal portion 28 curved at 38, the distal portion 28could still be bent between the location 37 and the terminal member 7for directing the terminal member 7 out of the central major plane 35.In this way, the terminal member 7 would be directed out of both themajor and minor central planes 35 and 39, respectively.

In practice, bending of the distal portion 28 between the location 37and the terminal member 7 for urging the terminal member 7 out of thecentral major plane 35 would typically be carried out manually by asurgeon or a paramedic prior to inserting the guide wire 1 into thesubject. The curved portion 38 for directing the terminal member 7 outof the central minor plane 39 would normally be factory formed.

The amount by which the curved portion 38 of the distal portion 28 iscurved determines the amount by which the terminal member 7 is offsetfrom the central major plane 35, in other words, the amount of curvaturein the curved portion 38 determines the included angle θ which thecentral axis 9 of the terminal member 7 makes with the main central axis6, namely, the angular offset of the terminal member 7 relative to themain central axis 6. In FIG. 10 the angle θ is illustrated as being 90°,however, it will be readily apparent to those skilled in the art thatthe angle θ may be any desired angle, and typically will lie between 0°and 90°. The angle at which the portion of the distal portion 28 betweenthe location 37 and the terminal member 7 may be bent may be any desiredangle, and typically would be in the range from 0° to 90°.

In this embodiment of the invention the terminal member 7 is secured tothe distal portion 28 of the core wire 5 with the central major plane 26defined by the first and second surface portions 13 and 14 extendingperpendicularly to the central major plane 35 defined by the first andsecond major surfaces 32 and 33 of the distal portion 28 of the corewire 5. Accordingly, the leading edge portion 8 extends perpendicularlyto the central major plane 35 defined by the first and second majorsurfaces 32 and 33 of the distal portion 28 of the core wire 5. Thisfacilitates bending of the flattened distal portion 28 in the directionof the arrows A and B, see FIG. 6. However, it is envisaged that theterminal member 7 may be secured to the core wire 5 with the centralmajor plane 26 defined between the first and second surface portions 13and 14 of the terminal member 7 extending parallel to or coinciding withthe central major plane 35 defined between the first and second majorsurfaces 32 and 33 of the distal portion 28 of the core wire 5. In whichcase the leading edge portion 8 would extend parallel to or coincidewith the central major plane 35 defined by the first and second majorsurfaces 32 and 33 of the distal portion 28 of the core wire 5.

In use, the guide wire 1 is urged through the vascular system of thesubject towards the occluded vessel. On reaching the occluded vessel,the guide wire is gradually urged forward and the leading edge portion 8of the terminal member 7 engages the occlusion and commences penetrationthereof. As the leading edge portion 8 penetrates the occlusion, thefirst and second surface portions 13 and 14 commence to gradually openthe occlusion, and further urging of the guide wire 1 causes theterminal member 7 to open the occlusion with the diameter of the openingformed in the occlusion corresponding to the diameter of the terminalmember 7 adjacent the guide wire 1. Further urging of the guide wire 1through the occlusion maintains the occlusion open with a diametercorresponding to that of the terminal member 7. Thereafter a catheter(not shown) is passed over the guide wire 1 and is guided into theocclusion. If the guide wire 1 is carrying a balloon, stent or othertherapeutic device, the device is located in the opening formed in theocclusion by the terminal member 7, and the guide wire 1 and thecatheter (not shown) are removed.

Prior to entering the guide wire 1 into the vascular system of thesubject, the guide wire 1 may be bent adjacent the terminal member 7thereof by bending the distal portion 28 between the location 37 and theterminal member 7 in the direction of the arrows A or B for facilitatingaligning of the terminal member 7 with a branched vessel of the vascularsystem as the guide wire 1 is being urged through the vascular system.Additionally, as mentioned above, the guide wire 1 may be supplied withthe curved portion 38 already formed in the distal portion 28 asillustrated in FIG. 10, and if desired, the distal portion 28 may bebent between the location 37 and the terminal member 7 for urging theterminal member 7 out of the central major plane 35 for furtherenhancing alignment of the guide wire 1 with a branched vessel of thevascular system.

It is also envisaged that the terminal member 7 may be provided withwells or holes on its outer surface, in particular, along the first andsecond surface portions 13 and 14 for retaining therapeutic drugs orother compositions, liquid or otherwise, for assisting in urging of theguide wire 1 through the vascular system, and in particular, forassisting in urging the terminal member 7 through the occlusion orpartial occlusion. Such drugs or other compositions, which may be inliquid, powder or other suitable form, may be drugs which wouldfacilitate in dilation of a vessel, or dissolving the material of theocclusion. For example, if the occlusion were caused by a thrombosis,one of the drugs may be suitable for dissolving the thrombosis.

Referring now to FIG. 11, a terminal member, indicated generally by thereference numeral 50, of a guide wire (not shown) also according to theinvention is illustrated. In this embodiment of the invention the corewire and sleeve of the guide wire are similar to the core wire 5 and thesleeve 10 of the guide wire 1 of FIGS. 1 to 10. The terminal member 50is substantially similar to the terminal member 7, and similarcomponents are identified by the same reference numerals. In thisembodiment of the invention a proximal portion 51 of the terminal member50 is of outer circular transverse cross-section, and the terminalmember 50 terminates in a leading edge portion 8 similar to the leadingedge portion 8 of the terminal member 7. However, while an axial bore 19extends into the terminal member 50 for engaging the distal end 4 of thecore wire 5, the terminal member 50 is provided without a plug similarto the plug 17 of the terminal member 7. In this case the helical coil10 would be abutted against an end face 52, and would be brazed orsoldered to the end face 52 with the outer surface defined by thehelical coil coinciding with the outer surface defined by the proximalportion 51 of the terminal member 50. The soldering or brazing of thehelical coil 10 to the end face 52 of the terminal member 50 could becarried out simultaneously with soldering or brazing the core wire 5into the bore 19 of the terminal member 50, or after the terminal member50 had been brazed or soldered to the core wire 5.

Referring now to FIG. 12, there is illustrated a terminal member 55 of aguide wire (not shown) also according to the invention. In thisembodiment of the invention the core wire and the sleeve of the guidewire are similar to the core wire 5 and the sleeve 10 of the guide wire1 of FIGS. 1 to 10. The terminal member 55 is substantially similar tothe terminal member 7 and similar components are identified by the samereference numerals. In this embodiment of the invention an axial plug 17extends from the terminal member 55, however, the terminal member 55 isprovided without an axial bore similar to the axial bore 19 of theterminal member 7. Thus, in this embodiment of the invention the axialplug 17 engages the bore 12, helical coil 10, and the distal end of thecore wire 5 is abutted against an end face 56 of the terminal member 55and brazed or soldered thereto.

Referring now to FIG. 13, there is illustrated a terminal member 60 of aguide wire (not shown) also according to the invention. In thisembodiment of the invention the core wire and the sleeve of the guidewire are similar to the core wire 5 and the sleeve 10 of the guide wire1 of FIGS. 1 to 10. The terminal member 60 is substantially similar tothe terminal member 7, and similar components are identified by the samereference numerals. The terminal member 60 comprises a proximal endportion 61 of circular transverse cross-section. However, in thisembodiment of the invention the terminal member 60 comprises a firstsurface portion 62 which converges towards a second surface portion 63,the outer transverse cross-sectional profile of which coincides with thecorresponding cross-sectional profile of the proximal end portion 61.The first surface portion 62 is convex in the longitudinal direction ofthe central axis 9 of the terminal member 60 and converges towards thesecond surface portion 63 in a direction towards the leading edgeportion 8 to form with the second surface portion 63, the transverselyextending leading edge portion 8. The surface 15 of the leading edgeportion 8 is radiused between the first and second surface portions 62and 63, and defines one straight edge 64 adjacent the first surfaceportion 62 and one arcuate edge 65 adjacent the second surface portion63. Additionally, side edges 66 of the first surface portion 62 areradiused to merge into the outer surface of the terminal member 60. Inthis embodiment of the invention the straight edge 64 of the leadingedge portion 8 is contained in a plane which extends parallel to a planecontaining the main central axis 6, but is offset therefrom.

Otherwise, the terminal member 60 is substantially similar to theterminal member 1.

The advantage of the terminal member 60 is that since the straight edge64 of the leading edge portion 8 is offset from the main central axis 6,the guide wire according to this embodiment of the invention can beguided through a vascular system to access a space between layers of avessel. This, thus, permits angioplasty or other surgical procedures tobe carried out in a new sub-intimal lumen. Sub-intimal angioplasty is atechnique where a lumen is created between the layers of the vesseladjacent to the true lumen of the vessel.

Referring now to FIG. 14, there is illustrated a terminal member 70 of aguide wire (not shown) also according to the invention. In thisembodiment of the invention the core wire and the sleeve of the guidewire are similar to the core wire 5 and the sleeve 10 of the guide wire1 of FIGS. 1 to 10. The terminal member 70 is substantially similar tothe terminal member 60 and similar components are identified by the samereference numerals. The main difference between the terminal member 70and the terminal member 60 is that the first surface portion 62 isconcave instead of convex. Otherwise, the terminal member 70 is similarto the terminal member 60. The advantage of providing the first surfaceportion 62 of concave shape as opposed to convex shape is that probingby the terminal member 70 may initially have less contact area due tothe concave surface.

Referring now to FIG. 15, there is illustrated a terminal member 75 of aguide wire (not shown) also according to the invention. In thisembodiment of the invention the core wire and the sleeve of the guidewire are similar to the core wire 5 and the sleeve 10 of the guide wire1 of FIGS. 1 to 10. The terminal member 75 is substantially similar tothe terminal member 60 and similar components are identified by the samereference numerals. The main difference between the terminal member 75and the terminal member 60 is that the first surface portion 62 isformed sequentially by a proximal convex portion 76 and a distal concaveportion 77. Additionally, the terminal member 75 is of a magneticmaterial, in this embodiment of the invention a ferrous material, sothat the terminal member 75 can be urged through the vascular system,and also through an occlusion in a vessel of the vascular system by amagnetic field generated by a magnetic urging means (not shown), whichwould be located externally of the subject. Such an urging means,typically, would develop a magnetic field which could be moved and/ordirected for urging the terminal member 75, and in turn, the guide wire(not shown) through the vascular system. Otherwise, the terminal member75 is similar to the terminal member 60.

The advantage of providing the terminal member 75 of a magnetic materialis that the member can be urged through the vascular system by anexternally generated magnetic field, rather than, by urging the terminalmember 75 through the vascular system by pushing the guide wire 1 intothe subject. By virtue of the fact that the terminal member 75 is urgedby a magnetic field through the vascular system, rather than by pushingthe guide wire 1 into the subject, minimizes the danger of the terminalmember 75 puncturing a vessel of the vascular system as the terminalmember 75 is being urged therethrough. Additionally, by virtue of thefact that the guide wire is being pulled rather than being pushed, theguide wire can be provided with considerably more flexibility than couldotherwise be provided if the guide wire were being pushed through thevascular system.

Referring now to FIGS. 16 to 18, there is illustrated a terminal member80 of a guide wire also according to the invention, only a distal endportion 81 of the guide wire is illustrated. In this embodiment of theinvention the core wire of the guide wire, the distal portion 28 ofwhich is illustrated, and the sleeve 10, the distal portion also ofwhich is illustrated, are similar to the core wire 5 and the sleeve 10of the guide wire 1 of FIGS. 1 to 10. The terminal member 80 is alsosubstantially similar to the terminal member 7 described with referenceto FIGS. 1 to 10, and similar components are identified by the samereference numerals. In this embodiment of the invention the terminalmember 80 is essentially formed by solder 82. The distal portion 28 ofthe core wire 5 extends beyond the sleeve 10, and is soldered to thesleeve 10 by the solder 82 which forms the terminal member 80. Theleading edge portion 8 of the terminal member 80 is formed by a distalend 83 of the distal portion 28 of the core wire 5, and the solder 82 isshaped to form the first, second, third and fourth surface portions 13,14, 18 and 21, respectively. However, in this embodiment of theinvention the outer surface of the terminal member 80 at the proximalend portion 16 of the terminal member 80 formed by the solder 82 is ofcircular cross-section, and is of similar diameter to the outer diameterof the sleeve 10. Additionally, as well as the first and second surfaceportions 13 and 14 tapering towards the leading edge portion 8 of theterminal member 80, the third and fourth surface portions 18 and 21 alsotaper from the proximal end portion 16 of the terminal member 80 to theleading edge portion 8. The first, second, third and fourth surfaceportions 13, 14, 18 and 21, respectively, are radiused surfaces, andthus, are convex in transverse cross-section relative to the maincentral axis 6. The distal portion 28 of the guide wire 5 is centrallylocated in the sleeve 10, and accordingly, the plane containing theleading edge portion 8 also contains the main central axis 6 of theguide wire.

Otherwise, the guide wire and the terminal member 80 according to thisembodiment of the invention is similar to the guide wire 1 and theterminal member 7, and their use is similar to that described withreference to the guide wire 1 of FIGS. 1 to 10.

Referring now to FIGS. 19 to 21, there is illustrated a terminal member85 of a guide wire (not shown) also according to the invention. In thisembodiment of the invention the core wire and the sleeve of the guidewire are similar to the core wire 5 and the sleeve 10 of the guide wire1 of FIGS. 1 to 10. The terminal member 85 is substantially similar tothe terminal member 7 of the guide wire 1 of FIGS. 1 to 10, and similarcomponents are identified by the same reference numerals. The maindifference between the terminal member 85 and the terminal member 7 isthat in the terminal member 85 the leading edge portion 8 extends at anangle φ to the main central axis 6, which in this embodiment of theinvention is approximately 70°.

Otherwise, the terminal member 85 and its use in conjunction with aguide wire is similar to the terminal member 7 of the guide wire 1described with reference to FIGS. 1 to 10.

Referring now to FIGS. 22 and 23, there is illustrated a terminal member90 of a guide wire (not shown) also according to the invention. In thisembodiment of the invention the core wire and the sleeve of the guidewire are similar to the core wire 5 and the sleeve 10 of the guide wire1 of FIGS. 1 to 10. The terminal member 90 is substantially similar tothe terminal member 7 described with reference to FIGS. 1 to 10 andsimilar components are identified by the same reference numerals. Themain difference between the terminal member 90 and the terminal member 7is that firstly, the leading edge portion 8 extends at an angle φ to themain central axis 6, which in this embodiment of the invention isapproximately 60.degree., and secondly, the third and fourth surfaceportions 18 and 21 converge from the proximal end portion 16 of theterminal member 90 to the leading edge portion 8. In this embodiment ofthe invention the first, second, third and fourth surface portions 13,14, 18 and 21 are radiused, and thus are convex in a transversedirection relative to the main central axis 6.

Otherwise, the terminal member 90 is similar to the terminal member 7.

Referring now to FIGS. 24 and 25, there is illustrated a terminal member95 of a guide wire (not shown) also according to the invention. In thisembodiment of the invention the core wire and sleeve of the guide wireare similar to the core wire 5 and the sleeve 10 of the guide wire 1 ofFIGS. 1 to 10. The terminal member 95 is substantially similar to theterminal member 7, and similar components are identified by the samereference numerals. The main difference between the terminal member 95and the terminal member 7 is that the leading edge portion 8 is radiusedin plan view, and thus, is convex in plan view. Otherwise, the terminalmember 95 is similar to the terminal member 7.

Referring now to FIGS. 26 and 27, there is illustrated a terminal member100 of a guide wire (not shown) also according to the invention. In thisembodiment of the invention the core wire and the sleeve of the guidewire are similar to the core wire 5 to and the sleeve 10 of the guidewire 1 of FIGS. 1 to 10. The terminal member 100 is substantiallysimilar to the terminal member 7, and similar components are identifiedby the same reference numerals. The main difference between the terminalmember 100 and the terminal member 7 is that the leading edge portion 8is radiused in plan view, and in this embodiment of the invention isconcave in plan view. Otherwise, the terminal member 100 is similar tothe terminal member 7.

Referring now to FIGS. 29 to 30, there is illustrated a terminal member105 of a guide wire (not shown) also according to the invention. In thisembodiment of the invention the core wire and the sleeve of the guidewire are similar to the core wire 5 and the sleeve 10 of the guide wireof FIGS. 1 to 10. The terminal member 105 is substantially similar tothe terminal member 7, and similar components are identified by the samereference numerals. The main difference between the terminal member 105and the terminal member 7 is that the portion of the terminal memberwhich extends between the proximal end portion 16 and the leading edgeportion 8 along which the first and second surface portions 13 and 14taper towards the leading edge portion is twisted through an angle ofapproximately 90°. Otherwise, the terminal member 105 is similar to theterminal member 7, and the use of the terminal member 105 and its guidewire is similar to the guide wire 1 described with reference to FIGS. 1to 10.

Referring now to FIGS. 31 and 32, there is illustrated a terminal member110 of a guide wire also according to the invention, only a distalportion 111 of the guide wire is illustrated in FIGS. 31 and 32. In thisembodiment of the invention the core wire, the distal portion 28 ofwhich is illustrated and the sleeve, a distal portion 10 of which isillustrated, of the guide wire are similar to the core wire 5 and thesleeve 10 of the guide wire 1 of FIGS. 1 to 10. The terminal member 110is substantially similar to the terminal member 7 of the guide wire 1 ofFIGS. 1 to 10, and similar components are identified by the samereference numerals. Additionally, the terminal member 110 of thisembodiment of the invention is somewhat similar to the terminal member80 described with reference to FIGS. 16 to 18. In this embodiment of theinvention the terminal member 110 is essentially formed by solder 112which solders the distal portion 28 of the guide wire to the sleeve 10of the guide wire. The main difference between the terminal member 110and the terminal member 80 is that in this embodiment of the inventionthe distal portion 28 of the core wire is wider than the distal portionof the guide wire of FIGS. 16 to 18, and thus, the leading edge portion8 of the terminal member 110 is longer than the leading edge portion 8of the terminal member 80. Additionally, the reinforcing rib 36 of thedistal portion 28 of the core wire 5, in this embodiment of theinvention, extends into the terminal member 110. The solder 112 isshaped to form the terminal member 110 in similar fashion as the solder82 is shaped to form the terminal member 80.

Otherwise, the terminal member 110 is similar to the terminal member 80,which in turn is substantially similar to the terminal member 7.

Referring now to FIGS. 33 and 34, there is illustrated a terminal member115 of a guide wire also according to the invention, only a distal end116 of the guide wire is illustrated. In this embodiment of theinvention the core wire and sleeve of the guide wire are similar to thecore wire 5 and the sleeve 10 of the guide wire 1 of FIGS. 1 to 10. Theterminal member 115 is substantially similar to the terminal member 110,which in turn is substantially similar to the terminal member 7, andsimilar components are identified by the same reference numerals. Themain difference between the terminal member 115 and the terminal member110 is that a distal portion extension 119 is secured to the distalportion 28 of the core wire 5, and is not centrally located in thesleeve 10. Rather, the distal portion extension 119 defines a centralmajor plane 135, which is parallel to but offset from a plane containingthe main central axis 6. As in the case of the terminal member 110, theterminal member 115 is essentially formed by solder 117, andaccordingly, by virtue of the fact that the distal portion extension 119is offset from the main central axis 6, the leading edge portion 8 ofthe terminal member 115, which is formed by a distal end 118 of thedistal portion extension 119 of the core wire 5, is contained in a planewhich extends parallel to a plane containing the main central axis 6 ofthe core wire, but is offset therefrom. Otherwise, the terminal member115 is substantially similar to the terminal member 110, which in turnis substantially similar to the terminal member 7.

Referring now to FIG. 35, there is illustrated a terminal member 120 ofa guide wire (not shown) also according to the invention. In thisembodiment of the invention the core wire and the sleeve of the guidewire are similar to the core wire 5 and sleeve 10 of the guide wire 1 ofFIGS. 1 to 10. The terminal member 120 is substantially similar to theterminal member 7, and similar components are identified by the samereference numerals. The main difference between the terminal member 120and the terminal member 7 is that in this embodiment of the inventiononly the first surface portion 13 is angled to converge with the secondsurface portion 14. Otherwise, the terminal member 120 is similar to theterminal member 7.

Referring now to FIGS. 36 and 37, there is illustrated a terminal member125 of a guide wire (not shown) also according to the invention. In thisembodiment of the invention the core wire and the sleeve of the guidewire are similar to the core wire 5 and the sleeve 10 of the guide wire1 of FIGS. 1 to 10. The terminal member 125 is substantially similar tothe terminal member 7, and similar components are identified by the samereference numerals. The main difference between the terminal member 125and the terminal member 7 is that a leading portion 126 of the terminalmember 125 is of wedge shape construction, and extends from anintermediate portion 127 which is located between the proximal endportion 16 and the leading portion 126. The leading portion 126 definesthe leading edge portion 8 which extends transversely relative to themain central axis 6 of the guide wire, and is contained in a plane whichalso contains the main central axis 6.

The first and second surface portions 13 and 14 extend from the proximalend portion 16 to the leading edge portion 8 and converge along theintermediate portion 127 and the leading portion 126. However, theportion of the first and second surface portions 13 and 14, which aredefined by the intermediate portion 127 are radiused, and thus, convexin a direction transversely of the main central axis 6, while theportion of the first and second surface portions 13 and 14 defined bythe leading portion 126 are planar surfaces. The third and fourthsurface portions 18 and 21, which are defined by the leading portion 126are planar surfaces, and extend parallel to each other. However, theportions of the third and fourth surface portions 18 and 20 which aredefined by the intermediate portion 127 converge from the proximal endportion 16 to the leading portion 126. The third and fourth surfaceportions 18 and 21 which are defined by the intermediate portion 127 areradiused, and thus, convex in a direction transversely of the maincentral axis 6 of the guide wire.

Otherwise, the terminal member 127 is similar to the terminal member 7.

Referring now to FIGS. 38 and 39, there is illustrated a terminal member140 of a guide wire (not shown) also according to the invention. In thisembodiment of the invention the core wire and the sleeve of the guidewire are similar to the core wire 5 and the sleeve 10 of the guide wire1 of FIGS. 1 to 10. The terminal member 140 is substantially similar tothe terminal member 7, and similar components are identified by the samereference numerals. The main difference between the terminal member 140and the terminal member 7 is that the acute angle α defined by the firstand second surface portions 13 and 14 is less than the acute angle αdefined by the first and second surface portions 13 and 14 of theterminal member 7, and accordingly, the length of the first and secondsurface portions 13 and 14 between the proximal end portion 16 and theleading edge portion 8 is longer in the terminal member 140 than it isin the terminal member 7. Additionally, the portion of the terminalmember 140 extending between the proximal end portion 16 and the leadingedge portion 8 is bent at an angle β out of the central major plane 26defined by the first and second surface portions 13 and 14, so that theleading edge portion 8 is offset from the main central axis 6, forfacilitating guiding of the terminal member 140, and in turn the guidewire into a branching vessel. Otherwise, the terminal member 140 issimilar to the terminal member 7, and its use along with the guide wireaccording to this embodiment of the invention is similar to that of theguide wire 1 described with reference to FIGS. 1 to 10.

While the guide wire according to the invention has been described foruse in opening an occluded vessel in the cardiovascular system of ahuman or animal subject, it will be readily apparent to those skilled inthe art that the guide wire according to the invention may be used foropening a vascular occlusion in any other vascular system of the humanor animal body.

While the sleeve extending around the core wire 5 adjacent its distalend has been described as being provided by a helical coil, any othersuitable sleeve may be provided, for example, in certain cases, it isenvisaged that the sleeve may be provided as a sleeve of plasticsmaterial, composite polymer material, or any other polymer material.

It will be appreciated that the guide wire may be produced of materialsother than those described, for example, the core wire may be of anyother suitable material besides stainless steel, for example, nickeltitanium alloy, MP35N; composite polymers, and the like. Similarly, thehelical coil or other sleeve may be of any other suitable materialbesides stainless steel, for example, nickel titanium alloy, MP35N,composite polymers, and the like, and the terminal member may be of anyother material besides platinum alloy, however, it is preferable thatthe terminal member or a portion thereof or a portion of the guide wireadjacent the terminal member should be of a radiopaque material. Wherethe terminal member is of a magnetic material, the magnetic material maybe any other suitable magnetic material besides that described withreference to the terminal member 75 of FIG. 15. Indeed, in certain casesit is envisaged that the terminal member may be constructed only partlyof a magnetic material. However, it is preferable that the terminalmember, even where it is of a magnetic material, should be of aradiopaque material for facilitating tracking of the terminal member asit is being urged through the vascular system.

Needless to say, while only the terminal member 75 has been described asbeing of a magnetic material, it will be readily apparent to thoseskilled in the art that any of the other terminal members described maybe of a magnetic material.

Needless to say, any other suitable securing means for securing theterminal member to the core wire and to the helical coil or other sleevemay be used besides soldering and brazing. Indeed, in certain cases, itis envisaged that the terminal member may be secured to the core wireand the helical coil or other sleeve by welding, adhesive or any othersuitable securing means. It is also envisaged in certain cases that theterminal member may be integrally formed with the core wire from thesame material.

Furthermore, while the terminal member in some of the embodiments of theinvention described with reference to the drawings has been described asbeing formed or partly formed by solder, it will be appreciated thatinstead of the terminal member being formed or partly formed by solder,it may be formed or partly formed by any other suitable material, forexample, a brazing material, a welding material, indeed, by an adhesiveor any other suitable filler material.

It is also envisaged that while in some of the embodiments of theinvention described with reference to the drawings the terminal memberhas been described as having a bore extending into the terminal memberfor engaging the distal portion of the core wire, in certain cases, itis envisaged that a plug portion may extend from the terminal member forsecuring to the distal portion of the core wire by any suitable securingmeans, for example, soldering, brazing, welding or adhesive. In whichcase, it is envisaged that, in general, the plug portion would be arelatively flat member in order to abut and lie parallel to one of themajor surfaces of the distal portion of the core wire.

Additionally, while the terminal members of the guide wires describedwith reference to the drawings in general have been described as havingfirst and second surface portions joined by third and fourth surfaceportions, which extend to the leading edge portion from the proximal endportion, it is envisaged in certain cases that a portion of the firstsurface portion may be formed by portions of the third and fourthsurface portions, so that when viewed from the distal end of theterminal member in the direction of the proximal end thereof, thetransverse cross-section of the terminal member would be substantiallytriangular. The base of the triangle forming the second surface portionand the leading edge portion, while the two sides of the triangle wouldform the third and fourth surface portions, or the first surfaceportion, depending on how the terminal member is viewed. In which case,it is envisaged that the surface portion of the terminal member formingthe base of the triangle may be planar or convex when viewed in atransverse direction, and the portions of the surface of the terminalmember forming the two sides of the triangle may be planar or convexwhen viewed in a transverse direction. In such cases, the first surfaceportion may be formed by the apex of the triangle defined by the thirdand fourth sides thereof, and the apex may be radiused or not radiused.

It is also envisaged that the third and fourth surface portions of theterminal member may be planar, convex or concave in a longitudinaldirection, or may be a combination of one or more of planar, concave andconvex in a longitudinal direction.

What is claimed is:
 1. A guide wire, comprising: a) a core wireextending longitudinally along a main central axis to a proximal corewire end and a distal core wire portion having a distal core wire end,wherein the distal core wire portion comprises first and second majorcore wire surfaces joined by opposed third and fourth minor core wiresurfaces, the first and second major core wire surfaces convergingtoward each other while the third and fourth minor core wire surfacesdiverge away from each other; b) a terminal member connected to andextending axially from the distal core wire end, wherein the terminalmember has opposed first and second planar terminal member surfaces thatconverge toward each other as they extend distally along the maincentral axis to a radiused leading edge, and wherein the first andsecond planar terminal member surfaces are joined by opposed third andfourth radiused terminal member surfaces, the third and fourth radiusedterminal member surfaces being convex in a transverse direction relativeto the central axis, wherein the radiused leading edge of the terminalmember extends to and meets with the third and fourth radiused terminalmember surfaces; and c) a reinforcing rib supported on one of the firstand second major core wire surfaces, the reinforcing rib terminatingproximal the distal core wire end.
 2. The guide wire of claim 1 whereinan included angle between the first and second planar terminal membersurfaces ranges from 5° to 6°.
 3. The guide wire of claim 1 wherein anincluded angle between the first and second planar terminal membersurfaces ranges from 12° to 30°.
 4. The guide wire of claim 1 wherein aradius of the radiused leading edge of the terminal member ranges from0.05 mm to 0.10 mm.
 5. The guide wire of claim 1 wherein a proximalportion of the terminal member has an axially extending bore receivingthe distal core wire end.
 6. The guide wire of claim 5 wherein thedistal core wire end is secured in the bore of the terminal member witha solder.
 7. The guide wire of claim 1 wherein a helical coil sleeve ismounted on the core wire with the core wire extending through a bore ofthe helical coil sleeve.
 8. The guide wire of claim 7 wherein a distalend of the coil sleeve is secured to a proximal end of the terminalmember.
 9. The guide wire of claim 8 wherein a first outer diameter ofthe distal end of the coil sleeve is similar to a second outer diameterof the proximal end of the terminal member.
 10. The guide wire of claim1 wherein the terminal member is of a radiopaque material.
 11. The guidewire of claim 1 wherein the distal core wire portion comprising theconverging first and second major core wire surfaces and the divergingthird and fourth minor core wire surfaces provides the core wirecomprising a spade-like configuration of a rectangular transversecross-section.
 12. The guide wire of claim 1 wherein the core wire isbendable so that a longitudinal axis of the terminal member is at anangle ranging from 90° to greater than zero with respect to main centralaxis of the core wire.
 13. The guide wire of claim 1 wherein theterminal member is configured as being capable of being urged through anocclusion by a magnetic urging means.
 14. A guide wire, comprising: a) acore wire extending longitudinally along a main central axis to aproximal core wire end and a distal core wire portion having a distalcore wire end, wherein the distal core wire portion comprises first andsecond major core wire surfaces joined by opposed third and fourth minorcore wire surfaces, and wherein the first and second major core wiresurfaces converge toward each other while the third and fourth minorcore wire surfaces diverge away from each other; b) a reinforcing ribsupported on one of the first and second major core wire surfaces, thereinforcing rib terminating proximal the distal core wire end; c) aterminal member connected to and extending axially from the distal corewire end, wherein the terminal member has opposed first and secondplanar terminal member surfaces that converge toward each other as theyextend distally along the main central axis to a radiused leading edge,and wherein the first and second planar terminal member surfaces arejoined by opposed third and fourth radiused terminal member surfaces,the third and fourth radiused terminal member surfaces being convex in atransverse direction relative to the central axis, wherein the radiusedleading edge extends to and meets with the third and fourth radiusedterminal member surfaces; and d) a helical coil sleeve providing a borereceiving the distal core wire end with a distal end of the coil sleevesecured to a proximal end of the terminal member, wherein a first outerdiameter of the distal end of the coil sleeve is similar to a secondouter diameter of the proximal end of the terminal member.
 15. The guidewire of claim 14 wherein the core wire is bendable so that alongitudinal axis of the terminal member is at an angle ranging from 90°to greater than zero with respect to the main central axis of the corewire.
 16. A guide wire, comprising: a) a core wire extendinglongitudinally along a main central axis to a proximal core wire end anda distal core wire portion having a distal core wire end, wherein thedistal core wire portion comprises first and second major core wiresurfaces joined by opposed third and fourth minor core wire surfaces,the first and second major core wire surfaces converging toward eachother while the third and fourth minor core wire surfaces diverge awayfrom each other; b) a terminal member connected to and extending axiallyfrom the distal core wire end, wherein the terminal member has opposedfirst and second planar terminal member surfaces that converge towardeach other as they extend distally along the main central axis to aradiused leading edge, and wherein the first and second planar terminalmember surfaces are joined by opposed third and fourth radiused terminalmember surfaces, the third and fourth radiused terminal member surfacesbeing convex in a transverse direction relative to the central axis,wherein the radiused leading edge extends to and meets with the thirdand fourth radiused terminal member surfaces; and c) a helical coilsleeve providing a bore receiving the distal core wire end with a distalend of the coil sleeve secured to a proximal end of the terminal member,d) wherein an included angle between the first and second planarterminal member surfaces ranges from 12° to 30° and a radius of theleading edge ranges from 0.05 mm to 0.10 mm.